title: Transdermal rotigotine in early stage Parkinson's disease: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  We conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan.
  
  
  METHODS
  Patients received once-daily rotigotine 2 to 16 mg/24 hours (mean dose, 12.8 mg/24 hours; n = 82) or placebo (n = 90) for 12 weeks. The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) part II (activities of daily living) and part III (motor function) scores from baseline to the end of treatment.
  
  
  RESULTS
  The mean (± standard deviation) changes in UPDRS part II and III scores were -8.4 ± 9.7 in the rotigotine group and -4.1 ± 8.2 in the placebo group and were significantly different (P = 0.002). More patients in the rotigotine group than in the placebo group had a ≥ 20% score reduction. No serious drug-related adverse events were reported.
  
  
  CONCLUSIONS
  Rotigotine at doses up to 16 mg/24 hours was well tolerated and improved function in patients with early stage PD.
authors.affiliation: Department of Neuroregeneration, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Yoshikuni
authors.initials: Y
authors.lastname: Mizuno
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nomoto
authors.forename: Tomoyoshi
authors.initials: T
authors.lastname: Kondo
authors.forename: Kazuko
authors.initials: K
authors.lastname: Hasegawa
authors.forename: Miho
authors.initials: M
authors.lastname: Murata
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takeuchi
authors.forename: Junji
authors.initials: J
authors.lastname: Ikeda
authors.forename: Takayuki
authors.initials: T
authors.lastname: Tomida
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Hattori
mesh_terms: D000279:Administration, Cutaneous; D000367:Age Factors; D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000978:Antiparkinson Agents; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine
keywords: Parkinson's disease; early stage Parkinson's disease; randomized controlled trial; rotigotine